A Randomized, Double-Blind, Placebo-Controlled, Phase IIB Study of the Safety and Efficacy of OVAREX MabB43.13 in Ovarian Cancer Patients With an Elevated Serum CA 125 But Without Other Evidence of Disease
oregovomab
Urogenital Diseases+18
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: November 1, 1998
Actual date on which the first participant was enrolled.OBJECTIVES: I. Determine the safety of OvaRex monoclonal antibody B43.13 in patients with elevated CA 125 and histologically proven epithelial adenocarcinoma of the ovary, fallopian tube, or peritoneum, but without other evidence of disease. II. Determine the time to disease progression, overall survival, CA 125 levels, immune responses, and quality of life of these patients treated with this regimen. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive placebo IV during weeks 1, 3, 5, 9, 13, 25, 37, and 49. Arm II: Patients receive OvaRex monoclonal antibody B43.13 (MOAB B43.13) IV during weeks 1, 3, 5, 9, 13, 25, 37, and 49. Patients in either treatment arm who have no disease progression after week 49 receive MOAB B43.13 once every 12 weeks until week 121. Patients with disease progression after week 49 may receive MOAB B43.13 alone, in combination with, or following chemotherapy. Quality of life is assessed during the study. PROJECTED ACCRUAL: A total of 102 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.102 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically proven epithelial adenocarcinoma of the ovary, fallopian tube, or peritoneum CA 125 greater than 35 U/mL No conclusive radiological or clinical evidence of disease No disease recurrence Must have received only 1 prior platinum based chemotherapy regimen No tumors of low malignant potential or noninvasive disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: Hemoglobin at least 8.0 g/dL Lymphocyte count at least 1,000/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No uncontrolled hypertension No congestive heart failure No arrhythmias Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active autoimmune disease requiring chronic treatment No allergy to murine proteins No documented anaphylactic reaction to any drug No active infection causing fever No immunodeficiency disease No uncontrolled nonmalignant diseases No other malignancy (except nonmelanomatous skin cancer or carcinoma in situ of the cervix) unless curatively treated and free of disease for at least 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibodies Chemotherapy: See Disease Characteristics At least 4 weeks since prior platinum based chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 6 months since prior limited field (i.e., abdominal or pelvic) radiotherapy No prior whole abdominal radiotherapy Surgery: At least 4 weeks since prior surgery No prior splenectomy Other: At least 4 weeks since prior immunosuppressive drugs No concurrent immunosuppressive drugs At least 30 days since other prior investigational drugs
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 16 locations
Gynecologic Oncology Associates
Newport Beach, United StatesOpen Gynecologic Oncology Associates in Google MapsLee Memorial Health System
Fort Myers, United StatesWalt Disney Memorial Cancer Institute
Orlando, United StatesH. Lee Moffitt Cancer Center and Research Institute
Tampa, United States